corheart 6 lvas study

Conditions: Refractory Heart Failure

Summary: the primary objective of this study is to evaluate the safety and effectiveness of the corheart 6 lvas when used for the treatment of advanced left ventricular heart failure in a european population at 6 months post-implantation. the secondary objective is to assess the long-term safety and effectiveness of corheart 6 lvas treatment.


Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years and ≤ 75 years * 2. the patient has signed an informed consent form * 3. body surface area (bsa) ≥ 1.2 m\^2 * 4. new york heart association (nyha) class iv * 5. left ventricular ejection fraction (lvef) ≤ 25% * 6. despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following: * a. unable to exercise for hf, * or * if able to perform cardiopulmonary testing, with peak vo2 \<12 ml/kg/min and/or \< 50% predicted value; * b. progressive end-organ dysfunction (worsening renal and/or hepatic function, type ii pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (pcwp \> 20 mmhg and sbp \< 90 mmhg or ci \< 2.0 l/min/m2). * c. impella or iabp assisted; * d. inotrope dependent/unable to wean from inotropes. exclusion criteria: * 1. heart failure who can be treated with other therapy options (e.g. crt, crt-d, etc.) * 2. intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status. * 3. patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type ii. * 4. platelet count \< 100,000 x 10\^3/l (\< 100,000/ml). * 5. psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management. * 6. technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. * 7. presence of an active, uncontrolled infection. * 8. presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: * a. total bilirubin \> 51.3 umol/l (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically child-pugh b and c score. * b. history of severe chronic obstructive pulmonary disease (copd) defined by fev1/fvc \< 0.7, or fev1 \< 50% predicted. * c. fixed pulmonary hypertension with a most recent pvr ≥ 8 wood units that is unresponsive to pharmacologic intervention. * d. history of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (\> 70%) carotid artery stenosis * e. serum creatinine ≥ 265umol/l (3.0mg/dl) or requiring dialysis. * f. significant peripheral vascular disease (pvd) accompanied by rest pain or extremity ulceration. * 9. etiology of heart failure (hf) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis. * 10. uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant. * 11. history of confirmed, untreated abdominal aortic aneurysm (aaa) or thoracic aortic aneurysm (taa) \> 5 cm in diameter. * 12. uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (vf). * 13. stemi \<2 weeks before planned implantation. * 14. right ventricular failure as defined by one or more of the following: * a. severe depressed rv function in echocardiography * b. tapse \< 1.0 cm * c. cvp/pcwp ratio \> 0.63 * 15. planned bi-vad support prior to enrollment. * 16. cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function. * 17. history of any organ transplant. * 18. pre albumin \< 150 mg/l, or albumin \< 30g/l (3 g/dl). * 19. any condition other than hf that could limit survival to less than 24 months. * 20. positive pregnancy test if of childbearing potential. * 21. lactating mothers. * 22. participation in any other clinical investigation that is likely to confound study results or affect the study. * 23. patients who have been placed in an institution by court order or by order of the authorities.

Keywords: advanced heart failure left ventricular assist system mechanical circulatory support